Method and apparatus for the surgical repair of aneurysms

ABSTRACT

An attachment assembly and repair graft are disclosed for securing a graft to repair a vessel having an aneurysm therein. The attachment assembly comprises an attachment cuff such that the graft is not dimensionally dependent upon the size of the vessel. A visualization apparatus is also disclosed for real time direct viewing of an interior of a vessel. A penetration apparatus is disclosed for use in forming treatment specific holes in a potentially calcified vessel wall which facilitates thereafter the securing of the graft and attachment assembly to the vessel wall. An introducer sheath device is also disclosed that comprises a sealing assembly for preventing the loss of blood from the vessel during the insertion and subsequent removal of surgical components during the surgical procedure.

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 60/051,209, entitled "METHOD AND APPARATUS FOR THE SURGICAL REPAIROF ANEURYSMS" filed on Jun. 30, 1997.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods and apparatus for the repair ofabdominal aortic aneurysms using a novel prosthetic tube graft withinthe abdominal aorta.

2. Description of Related Art

An aneurysm is a ballooning of the wall of an artery resulting from theweakening of the artery due to disease or other conditions. Leftuntreated, the aneurysm will frequently rupture, resulting in loss ofblood through the rupture and death.

Aortic aneurysms are the most common form of arterial aneurysm and arelife threatening. The aorta is the main artery which supplies blood tothe circulatory system. The aorta arises from the left ventricle of theheart, passes upward and bends over behind the heart, and passes downthrough the thorax and abdomen. Among other arterial vessels branchingoff the aorta along its path, the abdominal aorta supplies two sidevessels to the kidneys, the renal arteries. Below the level of the renalarteries, the abdominal aorta continues to about the level of the fourthlumbar vertebrae (or the navel), where it divides into the iliacarteries. The iliac arteries, in turn, supply blood to the lowerextremities and perineal region.

It is common for an aortic aneurysm to occur in that portion of theabdominal aorta between the renal arteries and the iliac arteries. Thisportion of the abdominal aorta is particularly susceptible to weakening,resulting in an aortic aneurysm. Such an aneurysm is often located nearthe iliac arteries. An aortic aneurysm larger than about 5 cm indiameter in this section of the aorta is ominous. Left untreated, theaneurysm may rupture, resulting in rapid, and usually fatal,hemorrhaging. Typically, a surgical procedure is not performed onaneurysms smaller than 5 cm because no statistical benefit exists inperforming such procedures.

Aneurysms in the abdominal aorta are associated with a particularly highmortality rate; accordingly, current medical standards call for urgentoperative repair. Abdominal surgery, however, results in substantialstress to the body. Although the mortality rate for an aortic aneurysmis extremely high, there is also considerable mortality and morbidityassociated with open surgical intervention to repair an aortic aneurysm.This intervention involves penetrating the abdominal wall to thelocation of the aneurysm to reinforce or replace the diseased section ofthe aortic aneurysm. A prosthetic device, typically a synthetic tubegraft, is used for this purpose. The graft serves to exclude theaneurysm from the circulatory system, thus relieving pressure and stresson the weakened section of the aorta at the aneurysm.

Repair of an aortic aneurysm by surgical means is a major operativeprocedure. Substantial morbidity accompanies the procedure, resulting ina protracted recovery period. Further, the procedure entails asubstantial risk of mortality. While surgical intervention may beindicated and the surgery carries attendant risk, certain patients maynot be able to tolerate the stress of intra-abdominal surgery. It is,therefore, desirable to reduce the mortality and morbidity associatedwith intra-abdominal surgical intervention.

In recent years, methods have been developed to attempt to treat anaortic aneurysm without the attendant risks of intra-abdominal surgicalintervention. Among them are inventions disclosed and claimed inKomberg, U.S. Pat. No. 4,562,596 for Aortic Graft, Device and Method forPerforming an Intraluminal Abdominal Aortic Aneurysm Repair; Lazarus,U.S. Pat. No. 4,787,899 for Intraluminal Graft Device, System andMethod; and Taheri, U.S. Pat. No. 5,042,707 for Intravascular Stapler,and Method of Operating Same.

Kornberg discloses an aortic graft comprising a flexible tubularmaterial having a plurality of struts to lend the graft stability andresiliency. The struts have angled hooks with barbs at their upper endswhich are securely attached to the inside of the aorta above theaneurysm. Komberg's graft is inserted using a tubular device alsodisclosed in his patent. Kornberg, however, only anchors the proximalend of the graft. Komberg claims that the downward flow of blood holdsthe distal graft securely in place, so that no mechanical attachment isnecessary distally. The blood pressure in the abdominal aorta, however,is typically in the magnitude of 130 mm of mercury (Hg). In spite of thedirection of flow of blood through the graft, proximal to distal,substantial back pressure within the aneurysm will result unless thedistal end is also mechanically attached to the aorta in a manner thatprevents substantial leakage of blood between the graft and the aorta.Without distal attachment, the device of Kornberg will not effectivelyexclude the weakened arterial wall at the site of the aneurysm from theforces and stress associated with the blood pressure.

Lazarus discloses a grafting system that employs a plurality of staplesmounted in the proximal end of the graft. Lazarus's staples are forcedthrough the aorta wall by means of a balloon catheter. As does Komberg,Lazarus discloses staples mounted only in the proximal end of the graft.There is no teaching or suggestion in Lazarus, U.S. Pat. No. 4,787,899as to the desirability of, let alone means for, mechanically attachingthe graft to the distal aorta below the level of the aneurysm.

Taheri discloses an articulatable stapler for implanting a graft in ablood vessel. The stapler is in the form of an elongated catheter with aplurality of segments mounted on the distal end of the catheter. Thesegments have beveled faces and are connected to each other by hinges. Astylet runs through the catheter to the most distal segment. The mostdistal segment is moved, in conjunction with the other segments, into afiring position that is substantially perpendicular to the main catheterbody by the action of pulling on the stylet. The staple is implanted byusing two other stylets which act as fingers to bend the staple into itsattachment position.

Taheri, however, appears to be a single-fire design which can onlyimplant one staple at a time. After each stapler is implanted, Taheri'sdesign apparently requires that the catheter be removed before anotherstaple is loaded. In addition, Taheri's does not teach or suggest anappropriate density of staples to secure a graft against the pulsatileblood flow of the aorta. Pressures within the aorta range from 120 mm Hgpressure to 200 mm Hg pressure. Without adequate attachment, the graftmay leak around the edges continuing to allow life threatening pressuresto develop in the aneurysm, and may not even remain in place.

Hence, although in recent years certain techniques have been developedthat may reduce the stress, morbidity, and risk of mortality associatedwith surgical intervention to repair aortic aneurysms, none of thesystems that have been developed effectively treat the aneurysm andexclude the affected section of aorta from the pressures and stressesassociated with circulation. None of the devices disclosed in thereferences provide a reliable and quick means to reinforce an aneurysmalartery. In addition, all of the prior references require a sufficientlylarge section of healthy aorta surrounding the aneurysm to ensureattachment of the graft. The neck of the aorta at the cephalad end(i.e., above the aneurysm) is usually sufficient to maintain a graft'sattachment means. However, when an aneurysm is located near the iliacarteries, there may be an ill-defined neck or no neck below theaneurysm. Such an ill-defined neck would have an insufficient amount ofhealthy aortic tissue to which to successfully mount a graft.Furthermore, much of the abdominal aorta wall may be calcified which maymake it extremely difficult to attach the graft to the wall.

There are a number of shortcomings with the presently available graftproducts and their fixation within the abdominal aorta. Although sizingof "tube" or "bifurcated" grafts is radiographically assessed prior tosurgery, it is necessary for the surgeon to have a large selection ofgraft lengths and diameters on hand to ensure an appropriate surgicaloutcome. Additional shortcomings include the placement of a "circular"profile graft with an associated fixation device within an essentially"ovoid" profile vessel and the use of attachment means which fasten onlyto the insubstantial, structurally compromised (diseased) intima andmedia levels of the vessel wall. Research has exposed yet anotherproblem which indicates that the necks of the post-surgical aortaincrease in size for approximately twelve months, regardless of whetherthe aneurysm experiences dimensional change. This phenomenon can resultin perigraft leaks and graft migration.

There are a number of currently available scanning technologies thatfacilitate the pre-surgical assessment of abdominal aortic aneurysms.These include: computed tomography; magnetic resonance angiography;computed angiography; sonography including Doppler, and color flow;abdominal aortography; contrast arteriography; magnetic resonanceimaging (i.e., MRI); and echocardiography. The images gained by thesescanning technologies are informative, but are open to multipleinterpretations as they do not provide direct viewing of the portion ofthe aorta to be repaired. Furthermore, the performance of the proceduresfor these technologies may be injurious to the patient and in otherinstances impractical.

OBJECTS OF THE INVENTION

It is therefore an object of the present invention to provide a new andimproved method of repairing an abdominal aorta aneurysm.

It is another object of the present invention to provide an apparatusfor facilitating the repair of an abdominal aneurysm.

It is another object of the present invention to provide a graft for therepair of an abdominal aneurysm.

It is an object of the present invention to provide an apparatus for therepair of the aneurysm that facilitates direct viewing of the area ofthe aneurysm to be repaired.

It is another object of the present invention to reduce the amount ofdamage to the aorta and associated vasculature while repairing theaneurysm.

It is another object of the present invention to facilitate directviewing of the vessel wall surface to assist the medical practitioner(i.e., surgeon or interventional radiologist) in the repair of vessel.

It is an object of the present invention to exclude an aneurysm from thecirculatory system.

It is an object of the present invention to create a device for therepair of an aneurysm that can, without negative consequences, navigatethe vessels extending to and from the aorta.

It is another object of the present invention to localize a graft withinthe abdominal aorta between the proximal and distal ends of the aorta.

It is an object of the present invention to firmly fasten a graft to theadventitia of the vessel wall to prevent migration of the graft.

It is another of object of the present invention to create a device toclearly visualize the surgical site during repair of the aneurysm.

It is another object of the present invention to create a uniformuniversal graft that is sized for use in a range of patients.

It is another object of the present invention to create a graft whoseperformance is not adversely effected by post surgical dimensionalchanges in the aortic necks.

It is another object of the present invention to create a device for therepair of the abdominal aortic aneurysm which may in addition to theclassic femoral/common iliac introduction, also may be introduced viathe axillary and/or brachial artery, which has not previously beencontemplated.

It is another object of the present invention to provide a seal detailwithin an introducer sheath device that will significantly reduce bloodloss during the repair procedure.

It is another object of the present invention to provide fastenerassemblies that replace sutures.

It is another object of the present invention to provide a device thatis capable of on board storage of a procedure specific quantity offasteners so that it is not necessary to remove the device to reloadduring the repair procedure.

It is another object of the present invention to create a graft and adevice for the repair of an aneurysm that reduces the invasiveness ofcurrent surgical procedures.

It is another object of the present invention to create a graft that isnot dimension dependent (i.e., diameter/length) which is adaptable tothe patient environment.

SUMMARY OF THE INVENTION

The present invention is directed to an attachment assembly for securinga graft to repair a vessel having an aneurysm therein. The vessel has aproximal neck or end and a distal neck or end. The graft has a proximalend and a distal end. The attachment assembly comprises attachment meansfor securing the distal end of the graft to the distal end of thevessel. The attachment assembly also comprises graft attachment meansfor securing the distal end of the graft to the attachment means. Theattachment means permits expansion of the vessel necks and/or endswithout negatively impacting the connection between the graft and thevessel wall. The attachment assembly may comprise a radially extendingcuff. The attachment means may comprise at least one graft attachmenttube for receiving the distal end of the graft. The attachment assemblyis preferably formed from a flexible material.

The present invention is also directed to a repair graft assembly forrepairing a vessel having an aneurysm therein. The repair graft assemblycomprises a graft assembly for creating a passageway within the vesselto reinforce the aneurysm. The graft assembly has a proximal end and adistal end. The repair graft assembly also comprises an attachmentassembly. The attachment assembly comprises attachment means forsecuring the distal end of the graft to the distal end of the vessel.The attachment assembly also comprises graft attachment means forsecuring the distal end of the graft to the attachment means. Theattachment means permits expansion of the vessel without negativelyimpacting the connection between the distal end of the graft and thevessel. The attachment assembly may comprise a radially extending cuff.The attachment means may comprise at least one graft attachment tube forreceiving the distal end of the graft. The repair graft assembly ispreferably formed from a flexible material. The attachment means of therepair graft assembly preferably comprises at least one graft attachmenttube for receiving the distal end of the graft assembly.

The repair graft assembly comprises proximal attachment means forsecuring the proximal end of the graft to the proximal neck or end ofthe vessel. The proximal attachment means comprises a radially extendingcuff.

The present invention is also directed to a visualization apparatus forviewing the interior of a vessel prior to, during and following asurgical procedure. The visualization apparatus comprises a housing andimage creating means for creating an image of the interior of the vesselfrom within the vessel. The image creating means is located within thehousing. The image creating means comprises illumination means forilluminating an area within the vessel for viewing by a user. The imagecreating means also comprises diverting means for temporarily divertingblood away from the viewing area. The image creating means alsocomprises optical viewing means for viewing the area within the vessel.

The illumination means may comprise at least one optical fiber forilluminating the area within the vessel.

The visualization means comprises means for supplying a fluid to thearea to direct the flow of blood away from the viewing area, and returnmeans for draining the fluid from the area to permit the return ofblood.

The optical viewing means comprises an optical fiber. The opticalviewing means may alternatively comprise scanning means for scanning anarea of the vessel for creating a non optical image of the area. Thescanning means may produce an ultrasound image. The scanning means maycomprise a scanning catheter.

The present invention is also directed to a penetration apparatus foruse in creating a plurality of treatment specific holes in the sometimescalcified vessel wall to aid in the attachment of a graft. Thepenetration apparatus comprises a housing, and penetration means for usein creating a plurality of treatment specific holes in the sometimescalcified vessel wall. The penetration means is located within thehousing. The penetration means may comprise a laser. The laser may be anacousto optical laser or a Holmium-Yag laser. Alternatively, thepenetration means may comprise a piezoelectric penetrating device. Thepenetration apparatus may also comprise insertion means for inserting afastener through the opening in the vessel to secure a surgicalcomponent (e.g., graft and prosthesis) to the vessel. The penetrationapparatus may also comprise secondary penetration means for forming atleast one opening adjacent the opening in the sometimes calcified vesselwall. The secondary penetration means may comprise a laser orpiezoelectric device. The secondary penetration means stabilizes thepenetration apparatus as the insertion means inserts a fastener in theopening. The penetration apparatus may further comprise visual trackingmeans for identifying the location of the penetration apparatus withinthe vessel.

The present invention is also directed to repair apparatus for repairinga vessel during a surgical procedure. The apparatus comprises a housingand at least one of a penetration apparatus for use in forming anopening in a vessel having a calcified portion and a visualizationapparatus for viewing an interior of a vessel during a surgicalprocedure. The penetration apparatus comprises a penetration housing,and penetration means for forming treatment specific holes in thesometimes calcified vessel wall. The visualization apparatus comprises avisualization housing, and image creating means for creating an image ofthe interior of the vessel from within the vessel.

The present invention is also directed to a fastener for use in asurgical procedure for securing a surgical component to a vessel. Thefastener comprises fastening means for securing the surgical componentto the vessel under a compressive force. The fastening means is either awire fabrication or a coil spring fabrication.

The present invention is also directed to an introducer sheath devicefor use during a surgical procedure for introducing surgical componentsinto a vessel. The introducer sheath device comprises a housing having apassageway that permits the passage of the surgical components therein.The introducer sheath device also comprises sealing means at theproximal end for preventing the loss of blood from the vessel during theinsertion and subsequent removal of surgical components during thesurgical procedure. The sealing means comprises a sealing cavity. Thesealing cavity is filled with a sealing material, which forms a sealaround the surgical components as they are inserted and removed from theintroducer sheath device during the surgical procedure. The introducersheath device further comprises positioning means for maintaining theposition of the introducer sheath device within the vessel. Thepositioning means preferably comprises an inflatable cuff positioned atthe distal end of the introducer sheath device.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in conjunction with the followingdrawings in which like reference numerals designate like elements andwherein:

FIG. 1A is a perspective view of a prosthetic bifurcated tube graft andbifurcated cuff according to a preferred embodiment of the presentinvention;

FIG. 1B is a perspective view of a prosthetic bifurcated tube graft andbifurcated cuff according to another embodiment of the presentinvention;

FIG. 2A is a perspective view of the prosthetic bifurcated tube graftand bifurcated cuff of FIG. 1A secured within the abdominal aorta;

FIG. 2B is a perspective view of the prosthetic bifurcated tube graftand bifurcated cuff of FIG. 1B secured within the abdominal aorta;

FIG. 3 is a perspective view of a prosthetic tube graft and cuffaccording to another embodiment of the present invention;

FIG. 4 is a perspective view of the prosthetic tube graft and cuff ofFIG. 3 secured within the abdominal aorta;

FIG. 5 is a perspective view of the connection between the prosthetictube graft and the cuff;

FIG. 6 is a side view of the prosthetic tube graft of FIG. 4 secured toa secondary cuff;

FIG. 7 is an exploded view of the connection between the prosthetic tubegraft and secondary cuff as shown in FIG. 6;

FIG. 8 is a perspective view of attachment cuffs according to anotherembodiment of the present invention;

FIG. 9 is a perspective view of the flexible attachment cuff accordingto embodiments of the present invention;

FIG. 10 is a perspective view of the attachment cuffs of FIG. 8 having aprosthetic tube graft secured between the attachment cuffs;

FIG. 11 is a perspective view of an IntraVascular Endoscopy (IVE) basedrepair system according to an embodiment of the present inventioncontaining an embodiment of a visualization device according to thepresent invention;

FIG. 12 is an end view of the IntraVascular Endoscopy (IVE) based repairsystem according to the embodiment of FIG. 11;

FIG. 13 is an end view of the visualization device depicted in FIG. 11;

FIG. 14 is another perspective view of the IntraVascular Endoscopy (IVE)based repair system illustrating the guide wire and articulation cablesexiting the housing of the repair system;

FIG. 15A is a perspective view of an IntraVascular Endoscopy (IVE) basedrepair system according to an embodiment of the present inventioncontaining an embodiment of a penetration device according to thepresent invention and an embodiment of a fastener cartridge according tothe present invention;

FIG. 15B is a perspective view of an IVE based repair system accordingto another embodiment of the present invention containing a penetrationdevice and fastener cartridge according to the present invention;

FIG. 15C is a perspective view of an IVE based repair system accordingto the embodiment of FIG. 15B containing a penetration device andfastener cartridge according to another embodiment of the presentinvention;

FIG. 15D is a perspective view of an IVE based repair system accordingto another embodiment of the present invention containing a penetrationdevice and fastener cartridge according to the present invention;

FIG. 16 is an end view of the penetration device according to anembodiment of the present invention;

FIG. 17 is an end view of the penetration device according to anotherembodiment of the present invention;

FIG. 18 is an end view of the fastener cartridge according to theembodiment of FIG. 15

FIG. 19 is a perspective view of an advancing mechanism of a penetrationdevice according to an embodiment of the present invention;

FIG. 20 is a schematic view of another advancing mechanism of apenetration device and fastener cartridge according to anotherembodiment of the present invention;

FIGS. 21 and 22 are perspective views of an IntraVascular UltraSound(IVUS) based repair apparatus according to another embodiment of thepresent invention containing a visualization device and a penetrationdevice;

FIG. 23 is a cross sectional view of a housing according to anembodiment of the present invention;

FIG. 24 is an end view of a penetration device depicted in FIG. 21;

FIGS. 25 and 26 are perspective views of a wire fastener for securingthe cuff detail of a surgical cuff to a vessel wall according to anembodiment of the present invention;

FIGS. 27 and 28 are perspective views of a wire fastener according toanother embodiment of the present invention for securing the cuff detailof a surgical cuff to a vessel wall;

FIGS. 29 and 30 are perspective views of a wire fastener according toanother embodiment of the present invention for securing the cuff detailof a surgical cuff to a vessel wall;

FIGS. 31, 32a, 32b, 32c, 32d and 32e are perspective views of a fasteneraccording to another embodiment of the present invention for securingthe cuff to a vessel wall;

FIG. 33 is a schematic view of an embodiment of the penetration deviceaccording to the present invention having fasteners, as shown in FIGS.31, 32a, 32b and 32c stored thereon;

FIG. 34 is a schematic view of an another embodiment of the penetrationdevice according to the present invention having fasteners, as shown inFIGS. 31, 32a, 32b and 32c stored therein;

FIGS. 35 and 36 are perspective views illustrating the fastenerattachment of the cuff detail to the vessel wall using a fastener asshown in FIGS. 29 and 30 according to an embodiment of the presentinvention;

FIG. 37 is a perspective view of another embodiment of an IntraVascularEndoscopy (IVE) based repair system according to an another embodimentof the present invention;

FIG. 38 is a perspective view on an introducer sheath device accordingto the present invention; and,

FIG. 39 is a cross sectional view of a seal assembly for the introducersheath device according to an embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following descriptions of the preferred embodiments of the presentinvention are described, for purpose of example, in connection with therepair of an abdominal aortic aneurysm. The inventors of the presentsubject matter contemplate that the embodiments described herein arecapable of use in the repair of other vessels and in other procedures.Thus, it is intended that the present invention cover the modificationsand variations of the invention, provided they come within the scope ofthe appended claims and their equivalents.

Repair Graft

Reference will now be made in detail to preferred embodiments of graftsaccording to the present invention for repair of abdominal aorticaneurysms, an example of which is illustrated in FIGS. 1-9.

FIGS. 1A and 2A depict a preferred embodiment of the repair graftassembly of the present invention directed to a proximal graft assembly10 and distal graft assembly 20 for repair of a vessel 1. The proximalgraft assembly 10 and distal graft assembly 20 are secured to a wall 2of the vessel 1 to exclude the aneurysm from the circulatory system ofthe patient. In the preferred embodiment of the present invention, theproximal graft assembly 10 is a bifurcated tube graft.

The distal graft assembly 20 preferably comprises an attachment cuff 21.The attachment cuff 21 is sized to secure the distal graft assembly 20to the wall 2 of the vessel 1 at the distal end of the vessel 1. Theattachment cuff is a generally radially extending flexible cuff, asillustrated in FIGS. 1-9. The attachment cuff is adapted to be securedto the vessel 1 and includes an inner open portion having an innerdiameter and a free outer perimeter portion having an outer diameter,which is greater than the inner diameter. The distal graft assembly 20also comprises at least one graft attachment leg, tube or branch 22. Theattachment cuff 21 is secured to the wall 2 of the vessel 1 out to theadventitia using a suitable fastener, described in detail below.

The distal graft assembly 20 is positioned within the distal end of thevessel 1, as shown in FIG. 1A using a guide wire, not shown, thatextends between and through both common iliacs. The attachment cuff 21is then secured to distal end of the vessel 1 out to the adventitiausing a repair apparatus, described below. After the attachment cuff 21is firmly secured to the wall 2, attachment tubes 22 are invaginated tothe position shown in FIG. 2A. A proximal graft assembly 10 is thensecured to the attachment legs 22 using suitable connectors, such as, aself-expanding stent 30, as shown in FIG. 5.

The bifurcated proximal graft assembly 10 comprises a pair of tubularlegs 11. The tubular legs 11 are sized to be received within/without thegraft attachment tubes 22. The bifurcated proximal graft assembly 10 mayalso comprise an attachment cuff 12 for attachment to the wall 2 of thevessel 1. The attachment cuff 12 has a similar structure to theattachment cuff 21 of attachment device 20. The tubular legs 11 areinvaginated following the process of securing the attachment cuff 12 tothe wall 2. The attachment legs 22 may be positioned within the tubularlegs 11, as shown in FIG. 2A. Alternatively, the tubular legs 11 may bepositioned within the attachment legs 22, as shown in the embodiment ofFIG. 4.

It is also contemplated that the distal graft assembly 20 may be usedwith a standard tube graft 3, as shown in FIGS. 1B and 2B. In thisvariation, the tube graft 3 is secured to the wall 2 of the vessel 1while in an inverted position, as shown in FIG. 1B using fasteners,described below, and a self-expanding stent 30, if desired. The tubegraft 3 is then invaginated and secured to the distal graft assembly 20,as described above. The benefit of the invagination of the graft 3 isthat the fasteners securing the graft 3 to the vessel 1 are not indirect contact with the blood within the vessel 1. This will reduce thepossible build up of thrombus at the point of attachment and thereafterthe creation of emboli.

The proximal graft assembly 10 and distal graft assembly 20 will enablethe creation of a cross sectional area ratio between the common iliacsand the distal aorta that exists only at childhood. The ratio may be 1.1to 1.0. This ratio minimizes the reflected wave that is instrumental inthe creation of plaque deposits at the distal bifurcation.

FIGS. 3 and 4 depict another embodiment of a repair graft for repair ofan abdominal aortic aneurysm or vessel 1 according to the presentinvention. The proximal graft assembly 100 is secured to a wall 2 of theabdominal aorta to exclude the aneurysm vessel 1 from the circulatorysystem of the patient. The proximal graft assembly 100 is used inconnection with the distal graft assembly 20, described above. In thisembodiment, the distal graft assembly 20 comprises a single attachmentleg or tube 22. The proximal graft assembly 100 comprises a tube graftassembly 110 for forming a passageway within the vessel 1.

The radially extending attachment cuff 122 provides a greater surfacearea for securing the proximal graft assembly 100 to the wall 2.Additionally, the radially extending portion 122 is flexible, whichpermits some positioning adjustment of the proximal graft assembly 100in the event the size of the passageway within the abdominal aortachanges after the surgical procedure. FIG. 9 illustrates the flexibilityof the attachment cuff 21 which is similar to attachment cuff 122. Likethe embodiment of FIGS. 1A and 2A, the proximal graft assembly 100 issecured to the vessel wall 2 in an invaginated manner, as shown in FIG.3. After the attachment cuff 122 is secured to the vessel wall 2, theproximal graft assembly 100 is invaginated to the position shown in FIG.4. The tubular leg assembly 110 is then secured to the distal graftassembly 20, as shown in FIG. 5. In a preferred embodiment, aself-expanding stent 30 is used to secure it to the attachment leg 22 ofthe distal graft assembly 20. The self-expanding stent 30 applies radialpressure against an inner surface of tube graft assembly 110 to securethe tube graft assembly 110 to the distal graft assembly 20.

The self-expanding stent 30 is a preferred method of securing theproximal tube assemblies 10 or 100 to the distal graft assembly 20.However, it will be apparent to those skilled in the art that variousmodifications and variations can be made in the construction andconfiguration of the present invention without departing from the scopeor spirit of the invention. For example, surgical staples, sutures,adhesives or other methods may be used to secure the proximal graftassembly 10 to the distal graft assembly 20. Thus, it is intended thatthe present invention cover the modifications and variations of theinvention, provided they fall within the scope of the appended claimsand their equivalents.

As described above in connection with FIGS. 1B and 2B, it is alsocontemplated that the distal graft assembly 20 may be used with astandard tube graft, not shown. The tube graft will also be secured tothe wall 2 of the vessel 1 while in a cephalad position using eitherfastener devices, described below, or a self-expanding stent 30. Thetube graft is then invaginated and secured to the distal graft assembly20, as described above.

FIGS. 6 and 7 depict a proximal attachment assembly 150 according to thepresent invention for securing the proximal graft assembly 10 or 100 tothe proximal end of the vessel 1. It is preferred that the proximalattachment assembly 150 be used in connection with securing the proximalgraft assemblies 10 or 100 to the vessel wall 2 according to preferredembodiments of the present invention as shown, for example, in FIGS. 3,4, 6 and 7. The proximal attachment assembly 150 comprises a cuffattachment portion 151 and a vessel attachment portion 152. Theattachment cuff 12 or 121 is secured to the cuff attachment portion 151,by sewing, for example. The vessel attachment portion 151 is thensecured to the vessel 1 using, for example, a fastener or aself-expanding stent 30 and fasteners, if necessary. Alternatively, theproximal attachment assembly 150 may be invaginated and secured to thevessel 1 in the manner described above in connection with FIGS. 1B and2B. The cuff attachment portion 151 and the attachment cuff 12 or 121interact in a manner such that the proximal graft assembly 10 or 100 arenot impacted by the expansion of the neck of vessel 1 after the surgicalprocedure.

Another embodiment of the repair grafts according to the presentinvention are disclosed in FIGS. 8 and 10. The embodiment of FIGS. 8 and10 utilizes a pair of distal graft assemblies 20, which are secured atthe proximal and distal ends of the vessel. A proximal graft assembly1000, which forms a passageway within the vessel 1 interconnects thedistal graft assemblies 20. As described above, the proximal graftassembly 1000 is secured to the attachment legs 22 of the distal graftassemblies 20 using a self-expanding stent 30 or other suitablefastening means. The attachment legs 22 may be inserted in the proximalgraft assembly 1000. Alternatively, the proximal graft assembly 1000 maybe inserted in the attachment legs 22, as shown in FIG. 10.

The above described repair grafts facilitates repair of a vessel in amanner that is neither profile nor dimension dependent. This isespecially helpful in view of the fact that the necks of thepost-surgical aorta typically increases in size for approximately twelvemonths. The above-described repair grafts accommodate such expansionwithout allowing leaks or graft migration. The attachment cuffs arecapable of accommodating dimensional changes in the necks of theabdominal aorta. Furthermore, the use of the distal graft assembly 20permits distal attachment removing the need for iliac/femoralattachment.

In the above described embodiments, the proximal graft assemblies 10,100 and 1000, distal graft assembly, and proximal attachment assembly150 are preferably formed from GoreTex® or equivalent biocompatiblematerial. It will be apparent to those skilled in the art that variousmodifications and variations can be made in the construction andconfiguration of the present invention without departing from the scopeor spirit of the invention. For example, in the embodiments mentionedabove, various other suitable materials such as, Dacron®, and otherbiocompatible graft materials may be used to form the repair grafts.Thus, it is intended that the present invention cover the modificationsand variations of the invention, provided they fall within the scope ofthe appended claims and their equivalents.

Similar to other graft procedures, the proximal graft assemblies 10,100, or 1000 according to the present invention require attachment tothe wall 2 of the vessel. Often, it is necessary to attach the distalend of the graft into material which is routinely calcified andtherefore difficult to penetrate. When paired with the absence of adistal neck in the vessel, the presence of the plaque has forced othersto promote the use of a bifurcated graft in which the graft limbs arefastened by stents within the common iliac or femoral arteries. Thisprocedure may potentially damage the femoral arteries. Furthermore, thepresence of a graft and stent within the iliac or femoral arteriespotentially restricts the flow of blood within the vessels. This isunnecessary when utilizing the repair grafts according to the presentinvention.

IntraVascular Endoscopy (IVE) Based Repair System

Reference will now be made in detail to preferred embodiments of anapparatus according to the present invention for facilitating the repairof abdominal aortic aneurysms using above described grafts. An exampleof an intravascular endoscopy based system is depicted in FIGS. 11-17.

The repair apparatus 5 comprises a housing 200 for alternately receivinga visualization apparatus 6 and a penetration apparatus 7, as shown inFIG. 15D. It, however, is contemplated by the inventors of the presentinvention that the visualization apparatus 6 and penetration apparatus 7may be combined into a single assembly within the repair apparatus 5.The housing 200 has a hollow construction, as illustrated in FIG. 12,which permits insertion of the visualization apparatus 6 or thepenetration apparatus 7, described in detail below. The housing 200 isdivided into two primary portions: static housing portion 210; andflexible housing portion 220. The housing 200 has a sufficient lengthsuch that it extends from the repair site within the vessel 1 throughthe appropriate or chosen artery to a point outside the patient.

The housing 200 has a hollow interior 211 to permit passage of one ofthe interchangeable apparatus 6 and 7. An inner surface of the hollowinterior 211 comprises rotation prevention means 212 for properlyorienting the interchangeable apparatus 6 and 7 within the housing 200.In a preferred embodiment, the rotation prevention means 212 is a ridge,as shown in FIG. 12, that extends along the inner surface of the hollowinterior 211. It, however, will be apparent to those skilled in the artthat various modifications and variations can be made in theconstruction and configuration of the present invention withoutdeparting from the scope or spirit of the invention. For example, therotation prevention means 211 mentioned above, may be located atdifferent radial positions within the housing and may also be a ridge, agroove, a plurality of grooves, or other devices capable of preventingrotation of the interchangeable apparatus 6 and 7 within the housing200. Thus, it is intended that the present invention cover themodifications and variations of the invention, provided they fall withinthe scope of the appended claims and their equivalents.

Positioned within the housing 200 is an apparatus guide means 214 forguiding the repair apparatus 5, as shown in FIGS. 11 and 15A, within thevessel 1 during use. The guide means 214 preferably is a passageway orlumen extending within the housing wall through the static portion 210.A guiding means 160 cooperates with guide means 214 to guide theapparatus 5 during use. The guiding means 160 is preferably a guide wirewhich is capable of extending from the femoral artery to the axillaryartery. In a preferred embodiment, the guide wire 160 is a filament(e.g., stainless steel, titanium or a Kevlar®). It, however, will beapparent to those skilled in the art that various other materials havingsimilar properties of physical integrity, high strength, flexibility,and minimal thermal expansion may be used to form the guide wire 160.The guide wire 160 projects from the flexible housing portion 220through an aperture 226 in the housing 200, as shown in FIG. 14.

Housing 200 also comprises an apparatus manipulation means 215 to aid inmanipulating and orienting the apparatus 5 within the vessel 1 duringthe repair operation. The manipulation means 215 preferably comprises atleast one passageway extending within the housing wall through thestatic housing portion 210 and terminating in the flexible housingportion 220. A manipulating means 170 cooperates with manipulation means215 to guide the apparatus 5 during use. The manipulating means 170 ispreferably comprises at least one guide wire that is capable ofextending from outside the patient through the housing 200. The guidewires 170 extend through the manipulating means 215. In a preferredembodiment, the guide wires 170 are filaments (e.g., stainless steel,titanium or a Kevlar®). It, however, will be apparent to those skilledin the art that various other materials having similar properties ofphysical integrity, high strength and flexibility may be used to formthe guide wires 170.

The guide wires of the manipulating means 170 terminate within theflexible housing portion 220. Operation of the manipulating means 170results in the articulation of an end portion of the flexible housingportion 220. The guide wires 170 maintain the flexible housing portion220 in an articulated position, as shown in FIGS. 11 and 14, such thatthe visualization apparatus 6 and the penetration apparatus 7 can beinterchanged without altering the orientation of the repair apparatus 5with respect to the surgical site.

The wall of the static housing portion 210 comprises an outer surfaceformed from silicone and an inner surface formed from Teflon®. It,however, will be apparent to those skilled in the art that variousmodifications and variations can be made in the construction andconfiguration of the present invention without departing from the scopeor spirit of the invention. For example, the housing wall may be formedfrom a suitable polymer (e.g., Pebax®) or other material having similarproperties including, but not limited to biocompatability, flexuralstrength, low coefficient of friction. Thus, it is intended that thepresent invention cover the modifications and variations of theinvention, provided they fall within the scope of the appended claimsand their equivalents.

The flexible housing portion 220 may be formed in a manner similar tostatic housing portion 210. For example, the housing may comprise anouter surface formed from silicon and an inner surface formed fromTeflon®. It, however, will be apparent to those skilled in the art thatvarious modifications and variations can be made in the construction andconfiguration of the present invention without departing from the scopeor spirit of the invention. For example, the lining may be formed from asuitable polymer or other material having similar properties including,but not limited to biocompatability, flexural strength, low coefficientof friction. Alternatively, the flexible housing portion 220 maycomprise a coiled metallic spring outer casing 224 that surrounds alining. The lining may be formed from Teflon®. The coiled metallicspring outer casing 224 may be formed from a biocompatible stainlesssteel or titanium. Furthermore, the spring outer casing 224 may beformed from other suitable spring materials. It is not necessary thatthe outer spring casing 224 extend along the entire length of theflexible housing portion 220. Rather, the outer spring casing 224 may bepositioned along the portion of the flexible housing portion 220 that issubject to bending. However, it is contemplated that an outer springcasing that extends along the entire length of the flexible housingportion 220 be within the scope of the present invention.

The flexible housing portion 220 and the static housing portion 210 aremanufactured as separate components. It, however, will be apparent tothose skilled in the art that various modifications and variations canbe made in the construction and configuration of the present inventionwithout departing from the scope or spirit of the invention. Forexample, the static housing portion 210 and the flexible housing portion220 may be formed as a single component. In a preferred embodiment, thestatic housing portion 210 is permanently secured to the flexiblehousing portion 220. However, it is contemplated that the housingportions 210 and 220 may also be removably attached.

FIGS. 15B and 15C illustrates another repair apparatus 500 foralternatively receiving a visualization apparatus 6 and a penetrationapparatus 7 according to another embodiment of the present invention.The repair apparatus 500 comprises a housing 2000 for alternativelyreceiving a visualization apparatus 6 and a penetration apparatus 7. Thehousing 2000 is flexible and has a sufficient length such that itextends from the repair site within the vessel 1 through the appropriateartery to a point outside the patient.

The housing 2000 is hollow, as described above in connection withhousing 200, to permit passage of one of the interchangeable apparatus 6or 7. The housing 2000 includes at least one guide means 2140 positionedat the exterior of the housing 2000 for guiding the repair apparatus 500within the vessel 1 during use. The guide means 2140 preferably is apassageway extending along the exterior of the housing wall to a pointadjacent the distal end 2001 of the housing 2000.

Guide wires 160 extend within the guide means 2140. The guide wires 160extend from the end of guide means 2140 and are secured to the distalend 2001 of the housing 2000, as shown in FIGS. 15B and 15C. Adjustmentof the guide wires 160 manipulates the position of the repair apparatus500 within the vessel 1. The above described arrangement permits a widerange of articulation of the repair apparatus 500 within the vessel 1.

An additional guide wire 161 is secured to the distal end 20001 of thehousing 2000. The guide wire 161 extends through the vessel 1 andappropriate artery to permit the positional adjustment of the repairapparatus 500 within the vessel.

FIG. 15D illustrates another repair apparatus 5000 for alternativelyreceiving a visualization apparatus 6 and a penetration apparatus 7according to another embodiment of the present invention. The repairapparatus 5000 comprises a flexible hollow housing 2010 and has asufficient length such that it extends from the repair site within thevessel 1 through the appropriate artery to a point outside.

The housing 2010 includes at least one guide wire 162 extending alongthe exterior of the housing 2010, as shown in FIG. 15D. The housing 2010includes an inflatable portion 2011, located adjacent the distal end2001. Inflation of the inflatable portion 2011 permits articulation ofthe repair apparatus 5000 within the vessel 1. A passageway, not shown,extends within the housing 2010 to permit inflation of the inflatableportion 2011 with a suitable fluid, such as, saline or suitable liquidpolymers or air. An additional guide wire 161 is secured to the distalend 2001 of the housing 2010. The guide wire 161 extends through thevessel 1 and appropriate artery to permit the positional adjustment ofthe repair apparatus within the vessel.

The overall dimensions of the repair apparatus 5 allows axillary access.This previously was not possible. In this regard, the repair apparatusused in connection with the visualization apparatus 6 or penetrationapparatus 7 is capable of being used in other surgical procedures notpreviously contemplated. The apparatus size permits insertion through anintroducer sheath device 900, described below. The apparatus 5 may alsobe introduced into a vessel percutaneously. This procedure is lessinvasive and/or intrusive when compared to other repair surgicalprocedures.

IntraVascular Endoscopy (IVE) Visualization Apparatus

Reference will now be made in detail to preferred embodiments of theinterchangeable apparatus 6 and 7 for use with the repair apparatus 5according to the present invention for facilitating the repair ofabdominal aortic aneurysms. The visualization apparatus 6 will now bedescribed in connection with FIGS. 11 and 13.

A visualization apparatus 6 may be inserted within the repair apparatus5 to illuminate and permit real time direct viewing of the abdominalaorta to aid and the diagnosis and repair of the aneurysm. Thevisualization apparatus 6 is an intravascular endoscope based systemthat comprises a housing 300 for housing various illuminating andviewing components. The housing 300 is preferably formed as a conduitthat is sized to slide within housing 200. In a preferred embodiment,the housing 300 is an extrusion of silicon, Teflon® or polymer or othermaterial having similar properties.

The housing 300 extends through the hollow interior 211 of the housing200. The housing 300 may comprise orientation means 310 for orientingthe visualization apparatus 6 within the housing 200. The orientationmeans 310 cooperates with rotation prevention means 212. In a preferredembodiment, the orientation means 310 is a channel that extends along anouter surface of the housing 300. It, however, will be apparent to thoseskilled in the art that various modifications and variations can be madein the construction and configuration of the present invention withoutdeparting from the scope or spirit of the invention. For example, theorientation means 310 mentioned above may be located at different radialpositions within the housing 300. The orientation means 310, may be aridge, a groove, a plurality of grooves, or other devices that arecomplementary with the rotation prevention means 212 to prevent rotationof the visualization apparatus 6 within the housing 200.

As shown in FIG. 13, housing 300 comprises a plurality of passageways311, 312, 313, 314, and 315 formed therein. The passageways 311, 312,313, 314, and 315 extend along the entire length of the housing 300.Central passageway 311 is provided for the passage of optical viewingmeans 320 for viewing an abdominal aorta. In a preferred embodiment, theoptical viewing means 320 is a fiber optic system. The systemincorporates a fiber optic bundle. It, however, will be apparent tothose skilled in the art that various modifications and variations canbe made in the construction and configuration of the present inventionwithout departing from the scope or spirit of the invention. Forexample, the optical viewing means 320 mentioned above, may be anyflexible optical system that is sized for use in surgical applications.The optical viewing means 320 permits real time direct viewing of thearea of repair in the vessel 1. The optical viewing means 320 may beconnected to a video camera and monitor, not shown, that permits thesurgeon to view the repair area. The images may be stored and recalledas desired by using either a video printer or video cassette recorder.The penetration apparatus 7 will be located at the same position as thevisualization apparatus 6. The penetration apparatus 7 incorporates aradio opaque marker that will indicate the precise position of thepenetration apparatus 7 on the monitor. This allows the surgeon tomonitor and track the adjustments of the repair apparatus 5.

Peripheral illumination passageways 312 and 313 are provided for thepassage of illuminating means 330 for illuminating the abdominal aortafor viewing by the optical viewing means 320. In a preferred embodiment,the illuminating means 330 is a fiber optic system including a fiberoptic bundle. It, however, will be apparent to those skilled in the artthat various modifications and variations can be made in theconstruction and configuration of the present invention withoutdeparting from the scope or spirit of the invention. For example, theilluminating means 330 mentioned above, may be any system that is sizedfor use in surgical applications and capable of illumination within theaorta. Although a pair of passageways are illustrated, it iscontemplated that a single illumination passageway will providesufficient illumination. Additionally, more than two passageways mayalso be provided.

Peripheral fluid inflow passageway 314 and peripheral fluid outflowpassageway 315 are provided for the passage of fluid lens media to andfrom the visualization tip 340. The peripheral fluid inflow passageway314 supplies a stream of optically clear fluid lens media from thevisualization tip 340 in the area in front of the optical viewing means320. A control means, not shown, may be incorporated into passageway 314to control the flow volume and velocity of the fluid lens media to thevisualization tip 340. The control means may be a valve or othersuitable flow control devices. The control means controls the opticallyclear fluid lens media such that blood within the aortic cavity and thefluid lens media are pressure balanced. As a result, blood that istypically within the aorta is temporarily diverted away by the fluidlens media to a point adjacent the area of the wall 2 to be viewed bythe optical viewing means 320. The infusion of fluid lens media willdilute blood to an appropriate transparency in the immediate surgicalsite to exclude blood between the visualization tip 340 and the surgicalsite on the wall 2. This permits the surgeon to clearly view the wall 2through the optical viewing means 320. In a preferred embodiment, thefluid lens is a transparent fluid to permit viewing of the wall 2. Thefluid lens media may be a saline solution. It is preferred that thesolution be used for a single application (i.e., it is not reused).Other media, such as CO₂ gas and GreenX liquid fluorocarbon arecontemplated to be within the scope of the present invention. Theperipheral fluid outflow passageway 315 acts as a return duct for thefluid lens media within the aorta. Alternatively, the fluid lens mediamay then be filtered using an appropriate filtering means andrecirculated using a pumping means through the peripheral fluid inflowpassageway 314.

In a preferred embodiment, it is contemplated that the visualizationapparatus 6 be used in combination with the introducer sheath devices900, described below. The introducer sheath devices 900 and inparticular the positioning assembies 920 permit the isolation of aportion of the vessel during the repair procedure. Specifically, thepositioning assemblies 920 within the common iliacs and femoral arterypermit the control of blood within the vessel. With this arrangement, itis then possible to more readily divert blood away from a viewing areawith the flow of fluid lens media from the fluid inflow passageway 314.

A visualization tip 340 is securely mounted to the end of housing 300 ina fluid tight manner. The tip 340 may be snap fitted or permanentlymounted to the housing 300. It, however, will be apparent to thoseskilled in the art that various modifications and variations can be madein the construction and configuration of the present invention withoutdeparting from the scope or spirit of the invention. For example, thevisualization tip 340 mentioned above, may be secured to the housing 300by means other than the above described snap and permanent fittings. Thevisualization tip 340 may be formed by injection molding or othersuitable manufacturing methods in silicone or similar polymer.

The visualization tip 340 comprises apertures 341, 342, 343, 344, and345 that correspond to passageways 311, 312, 313, 314, and 315,respectively. Aperture 341 contains a lens positioned therein tofacilitate viewing of the wall 2 with the optical viewing means 320.Apertures 342 and 343 may include windows therein whereby light from theilluminating means 330 passes through the windows to illuminate the wall2, although it is not necessary. Apertures 344 and 345 act as gates forthe peripheral fluid inflow passageway 314 and peripheral fluid outflowpassageway 315. The aperture 344 may be inwardly tapered, such that theinside diameter of the aperture adjacent the inflow passageway 314 isgreater than the diameter on the outer surface of the tip 340 toconcentrate the stream of fluid lens media from the fluid inflowpassageway 314. The aperture 345 may be outwardly tapered, such that theinside diameter of the aperture adjacent the inflow passageway 315 isless than the diameter on the outer surface of the tip 340. It iscontemplated that the tip 340 is optional.

Penetration Apparatus

A penetration apparatus 7 will now be described in connection with FIGS.15-20. The penetration apparatus 7 may be inserted within the repairapparatus 5, 500, 5000, as shown in FIGS. 15A-D, for fastening a repairgraft to the vessel wall 2. The penetration apparatus 7 comprisesseveral components for fastening a repair graft including penetrationmeans 420, secondary penetration means 430, tracking means 440 andinsertion means 450. The penetration apparatus 7 comprises housing 410for housing the penetration means 420, secondary penetration means 430,tracking means 440 and insertion means 450. In a preferred embodiment,the housing 410 has a thin walled tri-limbed profile, as shown in FIGS.15C, 16, and 17. In a preferred embodiment for increased flexibility,the housing 410 is positioned within the repair apparatus 5 such thattwo of the three limbs of the housing 410 are spaced from the side ofhousing 200 containing the guide wire 160. It, however, will be apparentto those skilled in the art that various modifications and variationscan be made in the construction and configuration of the presentinvention without departing from the scope or spirit of the invention.For example, the housing 410 mentioned above, may have more than threelimbs. Alternatively, the housing 410 may be cylindrical having aplurality of inwardly projecting limbs. An alternative configuration forhousing 4100 is depicted in FIGS. 15B and 15D. The housing 4100comprises a central passageway 4110 containing penetration means 420.Additional passageways 4210 and 4130 are provided for other componentssuch as secondary penetration means, tracking means and insertion means.

The housing 410 is preferably formed from an extrusion of silicone,Teflon®, or polymer having similar properties. Housing 410 comprises aplurality of passageways 411, 412, 413, and 414, formed therein as shownin FIG. 16. An alternative arrangement is shown in FIG. 17. Thepassageways 411, 412, 413, and 414 extend along the entire length of thehousing means 410. Primary passageway 411 is provided for the passage ofthe penetration means 420. The penetration means 420 is provided tocreate a treatment specific hole in the wall 2 of the abdominal aortafor securing the graft thereto with a suitable fastener device,described below. The penetration means 420 penetrates the potentiallycalcified vessel wall 2 to securely fasten the repair graft to the wall2. The penetration means 420 may be either a laser penetrating device ora piezoelectric penetrating device. It, however, is contemplated by theinventors of the present invention that other penetration meansincluding but not limited to CO₂ penetration, micro electromechanicalsystems, and intraluminal suturing are considered to be within the scopeof the present invention. The laser penetrating device 420 preferably isan IR fiber optic based system using laser energy to create treatmentspecific holes in the aorta wall 2. The fused silica/quartz fibers thatare utilized are in the 200-600 micron size range. Suitable laserscomprise but are not limited to an acousto optical laser having awavelength of about 1.35 μm, and a Holmium-Yag laser having a wavelengthof about 2.1 μm. The selected wavelength allows transition of laserenergy through the fiber in the passageway 411. The laser fiber will bein direct contact with the surgical site such that the fiber projectsfrom the end of the housing 410. It is contemplated that a single, ortri-pronged hole pattern will be created using penetration means 420 andsecondary penetration means 430.

The piezoelectric penetrating device preferably is a catheter basedsystem, which utilizes acoustic vibrations to create treatment specificsuture holes to aid in graft/tissue attachment. The piezoelectricpenetrating device applies an "acoustic wave" effect to create holes inthe graft and vessel wall. In this variation, the passageway 411preferably contains a super elastic titanium catheter, in rod or tubeform, which enables transmittance of energy through the sometimestortuous vessels to the surgical site. The catheter will be in directcontact with the surgical site such that the catheter projects from theend of the housing 410 into the formed treatment specific hole. Thesecondary penetration means 430 creates one or more temporary hole(s).The piezoelectronic device preferably operates at a frequency of 20 KHz.Other frequencys, both higher and lower, are contemplated to be withinthe scope of the present invention. The primary penetration means 420 iscoaxial with the fastener devices such that the fastener devices may beinserted through the treatment specific hole created by the primarypenetration means 420.

Secondary passageway 412 is provided for the passage of the secondarypenetration means 430. The secondary penetration means 430 is alsoprovided to create one or more temporary holes in the vessel wall 2, ina manner similar to the primary penetration means 420. Similarly, thesecondary penetration means 430 may be either a laser penetrating deviceor a piezoelectric penetrating device, as described above in connectionwith the penetration means 420. The secondary penetration means 430serves to anchor and orient the penetration apparatus 7 while a fasteneris inserted within the treatment specific hole formed by the primarypenetration means 420. After the secondary penetration means 430 isremoved, the temporary holes will seal with blood that will coagulate.

Passageway 413 is provided within the housing 410 for passage of theinsertion means 450, described below. Passageway 414 is provided withinthe housing means 410 for passage of the tracking means 440. In apreferred embodiment, the tracking means 440 is a radiopaque marker,which is utilized for the purpose of identifying the location of thepenetration apparatus 7 within the image on the monitor. It, however,will be apparent to those skilled in the art that various modificationsand variations can be made in the construction and configuration of thepresent invention without departing from the scope or spirit of theinvention. For example, the tracking means 440 mentioned above, may be atip-tracking device or a fiber optic aiming beam.

Insertion means 450 for securing the repair graft to the wall 2 duringrepair of the aneurysm will be described in connection with FIG. 19. Theinsertion means 450 preferably comprises a mechanism that drives anindividual fastener from a fastener cartridge 460, shown in FIGS. 15 and18, into and through the treatment specific holes created by thepenetration means 420 in the repair graft and wall 2. The fastenercartridge 460 is capable of holding a plurality of fasteners such thatmore than one fastener may be sequentially displaced from the cartridge460 to secure the repair graft to the abdominal aorta wall 2. Fastenercartridge 460 is preferably detachably connected to housing 410. Thefastener cartridge 460 is a hollow housing, as shown in FIG. 18,preferably formed of injection molding HDPE or Liquid Crystal,manufactured by the RTP Co. of MN. The penetration means 420 and 430,the tracking means 440 and the insertion means 450 are appropriatelyaccommodated within the interior of the cartridge structure 460. Thecartridge 460 is positioned about the housing 410.

The insertion means 450 illustrated in FIG. 19 comprises a driving means451 for driving the fastener devices to secure the repair graft to thevessel wall 2. A gear 452 and fastener advancing means 453 arepositioned within an opening 454 in housing 410. In a preferredembodiment, the gear 452 is a worm gear. However, other suitable gearassemblies are contemplated to be within the scope of the presentinvention. The gear 452 is connected to the driving means 451. Thefastener advancing means 453 interacts with the gear 452 to advance afastener device to secure the repair graft to the vessel wall 2. In apreferred embodiment, the fastener advancing means 453 is an internallygeared drive plate assembly. The drive plate assembly may be capable oflimited angular adjustment. Operation of the insertion means 450 iscontrolled by a control device, not shown, such that upon actuation bythe control device, the fastener advancing means 453 is advanced toeject a fastener device from fastener cartridge 460. Alternatively, theinsertion means 450 may be hand operated. The insertion means 450 isused, for example, in the embodiment illustrated in FIG. 15C.

Another embodiment of the insertion means 4500 is illustrated in FIG.20. An insertion cartridge 4510 is secured to the distal end of therepair apparatus 5. The insertion cartridge 4510 may be snap fitted tothe housing 200. The insertion cartridge 4510 comprises a cavity 4511. Aspring means 4520 is positioned within the cavity 4511. A fastenercartridge 460 is also located within the cavity 4511. An opening 4530 islocated at one end of the insertion housing 4510. The housing 410 of thepenetration apparatus 7 normally prevents the spring means 4520 fromejecting a fastener device through the opening 4530. The insertion means4500 comprises retraction means 4540 which retracts the housing 410 awayfrom the opening 4530 which permits the fastener to be ejected into thetreatment specific hole created by the primary penetration means 420.The retraction means 4540 may be a cable that acts to retract thehousing 410 away from opening 4530. The release of the retraction means4540 causes the housing 410 to return to the position adjacent theopening 4530 to prevent the discharge of a subsequent fastener device.

IntraVascular UltraSound (IVUS) Repair System

Reference will now be made in detail to preferred embodiments of anapparatus according to the present invention for facilitating the repairof abdominal aortic aneurysms using above described repair grafts. Anexample of an intravascular ultrasound based system is depicted in FIGS.21-24.

The repair apparatus 50 comprises housing 800. The housing 800 comprisesa major guide wire portion 810, a cross-section of which is shown inFIG. 23, a spacer portion 820, and a minor guide wire portion 830.

Positioned within the housing 800 is an apparatus guide means 214 forguiding the repair apparatus 50 within the vessel 1 during use. Theguide means 214 preferably is a passageway or lumen extending the lengthof the housing 800 through major guide wire portion 810, the spacerportion 820, and the minor guide wire portion 830. A guiding means 160cooperates with guide means 214 to guide the apparatus 50 during use.The guiding means 160 is preferably a guide wire which is capable ofextending from the femoral artery to the axillary artery. In a preferredembodiment, the guide wire 160 is a filament (e.g., stainless steel,titanium or Kevlar® cable). It, however, will be apparent to thoseskilled in the art that various other materials having similarproperties of physical integrity, high strength, flexibility, andminimal thermal expansion may be used to form the guide wire 160.

Housing 800 also comprises an apparatus manipulation means 215 to aid inmanipulating and orienting the penetration apparatus 700 within thevessel 1 during the repair operation. The manipulation means 215preferably comprises at least one passageway extending within thehousing 810. The manipulation means 215 mates with complimentarypassageways formed in housing 710. A manipulating means 170 cooperateswith manipulation means 215 to guide the apparatus 50 during use. Themanipulating means 170 is preferably comprises at least one guide wirethat is capable of extending from outside the patient through thehousings 810 and 710. The guide wire 170 extends through themanipulating means 215. In a preferred embodiment, the guide wire 170 isa super elastic metal filament. It, however, will be apparent to thoseskilled in the art that various other materials having similarproperties of physical integrity, high strength and flexibility may beused to form the guide wire 170.

Operation of the manipulating means 170 results in the articulation ofan end portion of the housing 710. The guide wire 170 maintains thehousing 710 in an articulated position, as shown in FIG. 21, during therepair operation.

The penetration apparatus 700 will now be described in connection withFIGS. 21-24. The penetration apparatus 700 comprises several componentsfor fastening a repair graft including penetration means 420, secondarypenetration means 430, tracking means 440, and insertion means 450. Thepenetration apparatus 700 comprises housing 710 for housing thepenetration means 420, secondary penetration means 430, and insertionmeans 450. In a preferred embodiment, the housing 410 has a thin walledtri-limbed profile, as shown in FIGS. 21, 22 and 24. It, however, willbe apparent to those skilled in the art that various modifications andvariations can be made in the construction and configuration of thepresent invention without departing from the scope or spirit of theinvention.

The housing 710 is preferably formed from an extrusion of silicone,Teflon®, or polymer having similar properties. Housing 710 comprises aplurality of passageways 711, 712, 713, 714, and 715 formed therein asshown in FIG. 24. The passageways 711, 712, 713, 714 and 715 extendalong the entire length of the housing 710. Primary passageway 711 isprovided for the passage of the penetration means 420. The penetrationmeans 420 is provided to create an treatment specific hole in the wall 2of the abdominal aorta for securing the graft thereto with a suitablefastener device. The penetration means 420 penetrates the calcifiedportions of the wall 2 to securely fasten the repair graft to the wall 2in the same manner as described above in connection with the endoscopicbased system. The penetration means 420 may be either a laserpenetrating device or a piezoelectric penetrating device.

Secondary passageway 712 is provided for the passage of the secondarypenetration means 430. The secondary penetration means 430 is alsoprovided to create one or more openings in the vessel wall 2, in amanner similar to the primary penetration means 420, as described above.

Passageway 713 is provided within the housing 710 for passage of theinsertion means 450. Passageway 714 is provided within the housing 710for passage of the guide wire 170. Passageway 715 is provided fortracking means 440. The insertion means 450 preferably comprises amechanism that drives an individual fastener from a fastener cartridge470, shown in FIGS. 21 and 22, into and through the treatment specificholes created by the penetration means 420 in the repair graft and wall2. The fastener cartridge 470 is capable of holding a procedure specificquantity of fasteners such that more than one fastener device may besequentially displaced from the cartridge 470 to secure the repair graftto the wall 2. Fastener cartridge 470 is preferably detachably assembledto housing 710. The fastener cartridge 470 has a hollow housing 471, asshown in FIG. 21. The penetration means 420 and 430, and theplacement/fastener means 450 are appropriately accommodated within theinterior of the cartridge structure 460. The cartridge structure 470 andassociated fastener device are complimentary with the spacer portion 820of the housing 800 such that the penetration apparatus 700 has a flushprofile, as shown in FIG. 22.

A visualization apparatus 600 for viewing the abdominal aorta to repairthe aneurysm is positioned within housing 800 adjacent the minor guidewire portion 830. The visualization apparatus 600 is an intravascularultrasound (IVUS) based system produced, for example, by Endosonics ofRancho Cordova, Calif., that comprises a housing 601 for housing radialscanning components. The housing 601 may comprise a scanning window 602,however, it is not essential for the effective operation of thevisualization apparatus 600. The visualization apparatus comprisesscanning catheter positioned within the housing 601 such that it scansthe area of the abdominal aorta. The housing 601 is an extrusion ofsilicon, Teflon® or polymer or other material having similar properties.The scanning catheter extends through the minor guide wire portion 830of housing 800. The scanning catheter creates an image of the repairthat can be viewed on an external monitor, not shown.

The housing 800 also comprise transition portions 801 and 802 located onopposite ends of the penetration apparatus 700 to provide the repairapparatus 50 with a smooth profile, as shown in FIG. 22. This improvesthe movement of the repair apparatus 50 within the vessel 1 and adjacentarteries.

Fasteners

Reference will now be made in detail to preferred embodiments of afastener device, as depicted in FIGS. 25-32, according to the presentinvention for securing the attachment device 20 to the distal end of thevessel 1. Although the fastener devices are described in connection withthe repair of an aneurysm in a vessel, the use of the fastener devicesin other surgical procedures as a replacement for sutures iscontemplated to be within the scope of the present invention.

FIGS. 25 and 26 depict a fastener 510 according to an embodiment of thepresent invention. The fastener 510 comprises a pair of normally splayedfastening legs 512 and 513. The fastener 510 also comprises an anchoringportion 514. The fastener 510 is preferably formed from a wire-likematerial. The anchoring portion 514 may be formed from a coil of thewire-like material. The legs 512 and 513 are temporarily reoriented, asshown in FIG. 25, for storage on a fastener cartridge 460 and forenabling the attachment of the attachment device 20 to the wall 2. Asthe legs 512 and 513 are inserted through the attachment device 20 andthe wall 2, the legs 512 and 513 return to a normal, as manufactured,splayed position, as shown in FIG. 26. When the fastener 510 is in afastened position within the vessel, the anchoring portion 514 ispositioned on one side of the attachment device 20 and wall 2(intima/graft) adjacent the attachment device 20. The splayed legs 512and 513 are positioned on the opposite side of the attachment device 20and wall 2 (adventia) adjacent the wall 2. The anchoring portion 514 andsplayed legs 512 and 513 apply compressive forces to the wall 2 and theattachment device 20 to securely fastening the attachment device 20 tothe vessel 1.

The fastener 510 is preferably formed from a stainless steel, such thatthe legs 512 and 513 return to the splayed position to secure theattachment device 20 to the wall 2. It, however, will be apparent tothose skilled in the art that various modifications and variations canbe made in the construction and configuration of the present inventionwithout departing from the scope or spirit of the invention. Forexample, the fastener 510 may be formed from other suitable materialsincluding but not limited to superelastic titanium, or otherprocedure/performance-appropriate materials having similar propertiesincluding, but not limited to biocompatability, elasticity, and flexuralstrength. Thus, it is intended that the present invention cover themodifications and variations of the invention, provided they fall withinthe scope of the appended claims and their equivalents.

FIGS. 27 and 28 depict a fastener 520 according to an another embodimentof the present invention. The fastener 520 comprises a pair of normallysplayed fastening legs 522 and 523. The fastener 520 also comprises ananchoring portion 524. The fastener 520 is also preferably formed from awire-like material. The anchoring portion 524 may be formed from atleast one coil of the wire-like material (i.e., a wound portion). Thelegs 522 and 523 are temporarily compressed, as shown in FIG. 27, forstorage in a fastener cartridge 460 and for facilitating the attachmentof the attachment device 20 to the wall 2. Similar to the embodimentdescribed above in connection with FIGS. 25 and 26, as the legs 522 and523 are inserted through the attachment device 20 and the wall 2, thelegs 522 and 523 return to a normally splayed position, as shown in FIG.27. When the fastener 520 is in a fastened position within the vessel,the anchoring portion 524 is positioned on one side of the attachmentdevice 20 and wall 2 adjacent the attachment device 20. The splayed legs522 and 523 are positioned on another side of the attachment device 20and wall 2 adjacent the wall 2. The anchoring portion 524 and splayedlegs 522 and 523 apply compressive forces to the wall 2 and theattachment device 20 to securely fastening the attachment device 20 tothe vessel 1.

FIGS. 29 and 30 depict a fastener 530 according to another embodiment ofthe present invention. Fastener 530 is a spring type fastener, which maycomprise a coil spring. The fastener 530 is also formed from a wire-likematerial. The fastener 530 comprises a plurality of coils, as shown inFIG. 29. The end portions 531 and 532 of the wire-like material arepreferably located on the same end of the fastener 530, as shown inFIGS. 29, 30, and 34-36. Unlike fastener 510 and 520, the fastener 530is temporarily elongated for storage in the fastener cartridge 535, asshown in FIGS. 33, 34, and 37. As the fastener 530 is inserted throughthe attachment device 20 and wall 2 using the insertion means 450 on thepenetration device 7, as shown in FIG. 35, the fastener 530 remains inan elongated position until the insertion means 450 is removed from thetreatment specific hole 3 created in the wall 2 of the vessel 1 and theattachment device 20 formed by the penetration apparatus 7. The fastener530 then assumes a collapsed position, as shown in FIG. 30. When thefastener 530 is in a fastened position within the vessel 1, the endportions 531 and 532 are positioned on one side of the attachment device20 and wall 2 adjacent the attachment device 20, as shown in FIG. 36.The remaining portion of the fastener 530 is positioned on another sideof the attachment device 20 and wall 2 adjacent the wall 2. The fastener530 applies compressive forces to the wall 2 and the attachment device20 to securely fastening the attachment device 20 to the vessel 1.Fastener 530 may be formed from a suitable stainless steel, asuperelastic alloy, or any other procedure/performance-appropriatematerials.

FIGS. 31, 32a, 32b, and 32c depict a fastener 540 according to anotherembodiment of the present invention. Fastener 540 is a coil spring typefastener. Fastener 540 comprises a mid-section 541, and semi-knotted endportions 542 and 543. The fastener 540 is also formed from a coil springusing materials, as described above. The fastener 540 is substantiallylinear, as shown in FIG. 31, for storage in a fastener cartridge, notshown. As the fastener 540 is inserted through the attachment device 20and wall 2, the fastener 540 returns to its normally coiled position, asshown in FIG. 32a. The fastener 540 applies compressive forces to thewall 2 and the attachment device 20 to securely fastening the attachmentdevice 20 to the vessel 1 such that one semi-knotted end portion 542 ispositioned adjacent the attachment device 20 and the other semi-knottedend portion 543 is positioned adjacent the wall 2 of the vessel 1, asshown in FIGS. 32b and 32c. FIG. 32b depicts an axially wound fastener540. FIG. 32d depicts the fastener 540 of FIG. 32b secured to the wall2. FIG. 32c depicts a radially wound fasteners 540. FIG. 32e depicts thefastener 540 of FIG. 32c secured to the wall 2.

It, however, will be apparent to those skilled in the art that variousmodifications and variations can be made in the construction andconfiguration of the present invention without departing from the scopeor spirit of the invention. For example, the fastening means mentionedabove, may be pop-rivet fasteners, screw-type fasteners, rapid hardeningplastic extrudates, and other suitable fasteners are contemplated to bewithin the scope of the present invention. Thus, it is intended that thepresent invention cover the modifications and variations of theinvention, provided they fall within the scope of the appended claimsand their equivalents.

Introducer Sheath Devices

Reference will now be made to a preferred embodiment of an introducersheath device according to the present invention of use in the repair ofabdominal aneurysms, an example of which is illustrated in FIGS. 38 and39. The introducer sheath devices create a protective passageway throughthe vessel through which the graft and repair devices are inserted. Theintroducer sheath devices protect the arteries from damage that mayoccur when the repair apparatus and other device are passed through thetortuous artery passageways during a surgical procedure.

Existing methods for repairing aneurysms utilize introducer sheathdevices only in the femoral and common iliac arteries. Typically, guidewires extend from a femoral arteriotomy to an occlusion balloon placedwithin the proximal neck of the aorta at a point cephalad with respectto the abdominal aorta. Typically, others have gained access to theabdominal aorta via a femoral or common iliac arteriotomy into which isinserted an introducer sheath device of between 18-28 Fr. diameter. Thesize of these devices may cause damage to the vessels through which theypass.

By contrast, the inventors of the present invention contemplate the useof more than one unique introducer sheath device 900, as shown in FIG.33. The sheaths 900 are introduced over a femoral/axillary guide wire.One introducer sheath device 900 extends from either an axillaryincision or a brachial incision to the proximal neck of the vessel 1.Another introducer sheath device 900 extends from a femoral incision tothe distal neck of the vessel or common iliac/distal aorta transition.The introducer sheath devices according to the present invention thatextend through the axillary vessel and through the femoral artery havesimilar constructions. However, the introducer sheath device thatextends through the axillary artery has a smaller size in the rangebetween 9-12 Fr. and is able to navigate the arteriotomy/distal aortapassageway without problem. The smaller size will permit access to theaorta via either the left brachial or axillary artery, both of which aresignificantly smaller than the femoral or common iliac arteries. Thisprocedure, previously, beyond consideration, may now significantlybenefit these vascular surgeries.

Each introducer sheath device 900 comprises a housing 910 having ahollow interior 911 that permits the passage of the tube graft and otherrepair apparatus through the introducer sheath device to the vessel 1.The repair apparatus are introduced through the an opening 912 in theend portion of the housing 910. In a preferred embodiment, the housing910 is a thin walled co-extrusion having an outer surface formed, forexample, from silicon and an inner surface formed, for example, fromTeflon®. Alternatively, the housing 910 may be formed of a suitablepolymer having similar properties.

The introducer sheath device 900, also, comprises positioning assembly920 for maintaining the sheath 900 in proper orientation within thevessel. In a preferred embodiment, the positioning assembly 920comprises an inflatable cuff 921 located at one end of housing 910. Thepositioning assembly 920 further comprises an inflation device forinflating the cuff 921. The inflation device in a preferred embodimentcomprises a plurality of passageways 923 formed within the wall ofhousing 910. A suitable fluid, such as saline, is supplied from anexternal source through the passageways 923 to fill the cuff 921. Thepassageways 923 terminate at inflatable cuff 921, as shown in FIG. 38.

Prior introducer sheath devices have not been able to control the lossof significant amounts of blood through the open end of the introducersheath device that is positioned outside of the body. Others haveattempted to prevent this blood loss through the use of complex clampingsystems. The present invention provide a unique seal arrangement toprevent significant blood loss. A seal 930 located at one end of thehousing 910 adjacent opening 912 will prevent significant blood loss.The seal 930 comprises an expanded housing assembly 931. A self-sealinggel-like material 932 is located within the expanded housing assembly931. The material 932 permits the insertion of the repair apparatusthrough the material 932, which forms a seal around the repairapparatus. As a the repair apparatus is removed from the introducersheath device 900, the material 932 forms a seal behind the repairapparatus as it is removed through opening 912.

It, however, will be apparent to those skilled in the art that variousmodifications and variations can be made in the construction andconfiguration of the present invention without departing from the scopeor spirit of the invention. It is intended that the present inventioncover the modifications and variations of the invention, provided theyfall within the scope of the appended claims and their equivalents.

Method of Repairing an Aneurysm

Reference will now be made in detail to a preferred embodiment of themethod of repairing an aneurysm utilizing the above described componentsaccording to the present invention.

IntraVascular Endoscopy (IVE) Based Repair Method

The IntraVascular Endoscopy (IVE) based repair method will be describedin connection with the use of a proximal graft assembly 10 and distalgraft assembly 20. Introducer sheath devices 900 are placed by femoralarteriotomy in both common iliacs under radiological guidance such thatthe positioning assembly 920 is positioned at the common iliac/aorticbifurcation transition. A guide wire is fed from one femoral incision tothe other, also under guidance. A distal graft assembly 20 is fed overthe guide wire until the attachment cuff 21 appears directly above thecarina at the bifurcation, as shown in FIG. 1A.

A second guide wire 160 is now fed under radiological guidance betweenone femoral incision and the left axillary incision. Another introducersheath device 900 is fed from the axillary until the positioningassembly 920 reaches the infrarenal aorta at which time it is inflated.The repair apparatus 5 is then fed through the introducer sheath device900 over guide wire 160 from either the femoral or axillary access tothe midpoint of the aortic aneurysm. The visualization apparatus 6 isthen fed through the hollow interior 211 of housing 200 to the area ofthe wall 2 to which the attachment cuff 22 is to be attached. The guidewires 170 are then manipulated to adjust the orientation of thevisualization apparatus 6 to permit viewing of the wall 2 as describedabove, such that an image appears on the monitor. An image of the wall 2appears on the monitor. The visualization apparatus 6 is then removedand the penetration apparatus 7 is then inserted through the hollowinterior 211. The guide wires 170, as described above, permit thepenetration apparatus to be positioned in the same position as thevisualization apparatus 6. The tracking means 440 pinpoints the locationof the penetration means 420 with respect to the wall 2 and attachmentcuff 22 as viewed on the monitor. The primary and secondary penetrationmeans 420 and 430 are then operated to form treatment specific holeswithin the cuff 22 and wall 2, as described above. The primarypenetration means 420 is then retracted and a fastener is then insertedwithin the treatment specific hole using the insertion means 450. Thelocation of the penetration apparatus 7 is then adjusted to repeat theprocess over the area previously viewed by the visualization apparatus6. The penetration apparatus 7 is then removed and the visualizationapparatus 6 is reinserted. The viewing and fastening process isalternately repeated until the attachment cuff 22 is firmly attached tothe wall 2.

The repair apparatus 5 is removed once the attachment cuff 22 is securedto the wall 2. The proximal graft assembly 10 is then inserted in aninverted manner through the femoral arteriotomy over the guide wire 160to the position shown in FIG. 1A. The repair apparatus 5 is then fedthrough the introducer sheath device 900 over the guide wire 160 fromeither a femoral or axillary access to a position adjacent theattachment cuff 12. The visualization apparatus 6 and the penetrationapparatus 7 are then alternately inserted in the manner described aboveto secure the attachment cuff 12 to the wall 2. In the event that astandard graft 3 is used, the inverted graft 3 is secured directly tothe wall 2 in a similar manner. Alternatively, a self-expanding stent 30may be used in combination with fasteners to secure the graft 3 to thewall 2. The repair apparatus 5 is then removed.

Once the proximal graft assembly 10 or 3 are secured in place, the firstguide wire is removed and the graft 3 or 10 is invaginated. The tubularlegs 11 are then inserted into the attachment tubes 22. Self-expandingstents 30 are then used to secure the attachment tubes 22 and tubularlegs 11 firmly together. The guide wire 160 is then removed. Thepositioning assemblies 920 are deflated and the introducer sheath device900 are removed from the femoral and axillary arteries. The incisionsare then closed completing the repair process. The outlined procedureaccording to the present invention is far less intrusive than currentknown techniques. As a result, a patient's recovery period shoulddecrease.

Intravascular Ultrasound Repair Method

The intravascular ultrasound repair method will be described inconnection with the use of a proximal graft assembly 10 and distal graftassembly 20. Introducer sheath device 900 are placed by femoralarteriotomy in both common iliacs under radiological guidance such thatthe positioning assembly 920, as described above in connection with theIntraVascular Endoscopy (IVE) based repair method. A distal graftassembly 20 is fed over a guide wire, as described above, until theattachment cuff 21 appears directly above the carina at the bifurcation,as shown in FIG. 1A.

A second guide wire 160 is now fed under guidance between one femoralincision and the left axillary incision. Another introducer sheathdevice 900 is fed from the axillary until the positioning assembly 920reaches the infrarenal aorta at which time it is inflated. The repairapparatus 50 is then fed through the introducer sheath device 900 overguide wire 160 to the midpoint of the aortic aneurysm. The visualizationapparatus 600 is then positioned adjacent the area of the wall 2 towhich the attachment cuff 22 is to be attached. The scanning catheter isdrawn caudad providing images of the distal aortal common iliactransition on an external monitor. The repair apparatus 50 is thenoriented such that the penetration apparatus 700 is adjacent the areawhere the attachment cuff 21 is to be attached to the wall 2.

The primary and secondary penetration means 420 and 430 are thenoperated to form treatment specific holes within the cuff 22 and wall 2,as described above. The primary penetration means 420 is then retractedand a fastener is then inserted within the treatment specific hole usingthe insertion means 450. The location of the penetration apparatus 700is then adjusted to repeat the process over the area previously viewedby the visualization apparatus 600. The repair apparatus 50 is thenoriented such that the visualization apparatus 600 may scan anotherportion of the wall 2. The viewing and mounting process is alternatelyrepeated until the attachment cuff 22 is firmly attached to the wall 2.

The repair apparatus 50 is removed once the attachment cuff 22 issecured to the wall 2. The proximal tube graft assembly 10 is theninserted in an inverted manner over the guide wire 160 to the positionshown in FIG. 1A. The repair apparatus 50 is then inserted through afemoral incision over the guide wire 160 to a position adjacent theattachment cuff 12. The visualization apparatus 600 and the penetrationapparatus 700 are then alternately operated in the manner describedabove to secure the attachment cuff 12 to the wall 2.

Once the proximal graft assembly 10 is secured in place, the first guidewire and the repair apparatus 50 are removed and the proximal graftassembly 10 is invaginated. The tubular legs 11 are then inserted intothe attachment tubes 22 or vice verse. Self-expanding stents 30 are thenused to secure the attachment tube 22 and tubular legs 11 firmlytogether. The guide wire 160 is then removed. The positioning assemblies920 are deflated and the introducer sheath devices 900 are removed fromthe femoral and axillary arteries. The incisions are then closedcompleting the repair process.

While this invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, the preferred embodiments of the invention as set forthherein are intended to be illustrative, not limiting. Various changesmay be made without departing from the spirit and scope of the inventionas defined in the following claims.

What is claimed is:
 1. An attachment assembly for securing a graft to avessel for repairing the vessel having an aneurysm therein, wherein thevessel has a vessel wall, a proximal end and a distal end and the grafthas a proximal end and a distal end, said attachment assemblycomprising:attachment means for securing the distal end of the graft tothe distal end of the vessel wall, wherein said attachment meansincludes a generally radially extending flexible cuff, said flexiblecuff includes an inner open portion having an inner diameter and a freeouter perimeter portion having an outer diameter, wherein said outerdiameter is greater than said inner diameter, wherein said radiallyextending flexible cuff being adapted to be secured to the vessel wall;and graft attachment means connected to said attachment means forsecuring the distal end of the graft to said attachment assembly,wherein said graft attachment means includes at least one graftattachment tube extending from said inner open portion of said flexiblecuff, wherein the graft is received within said at least one graftattachment tube, wherein said radially extending flexible cuffaccommodates expansion of the vessel without negatively impacting theconnection between the distal end of the graft and the vessel, whereinsaid radially extending flexible cuff laterally projects from said graftattachment means.
 2. The attachment assembly according to claim 1,wherein said attachment assembly is formed from a flexible material. 3.A repair graft assembly for repairing a vessel wall having an aneurysmtherein, wherein the vessel wall has a proximal end and a distal end,said repair graft assembly comprising:a proximal graft assembly forcreating a passageway within the vessel to reinforce the aneurysm,wherein said graft assembly having a proximal end and a distal end; andan attachment assembly comprising attachment means for securing saiddistal end of said proximal graft assembly to said distal end of thevessel wall, wherein said attachment means includes a generally radiallyextending flexible cuff, said flexible cuff includes an inner openportion having an inner diameter and a free outer perimeter portionhaving an outer diameter, wherein said outer diameter is greater thansaid inner diameter, wherein said radially extending flexible cuff beingadapted to be secured to the vessel wall, and graft attachment meansconnected to said attachment means for securing said distal end of saidproximal graft assembly to said attachment assembly, wherein said graftattachment means extends from said inner open portion of said flexiblecuff, wherein said radially extending flexible cuff accommodatesexpansion of the vessel without negatively impacting the connectionbetween said distal end of said proximal graft assembly and the vessel,wherein said radially extending flexible cuff laterally projects fromsaid graft attachment means.
 4. The repair graft assembly according toclaim 3, wherein said attachment assembly is formed from a flexiblematerial.
 5. The repair graft assembly according to claim 3, whereinsaid proximal graft assembly is formed from a flexible material.
 6. Therepair graft assembly according to claim 3, wherein said proximal graftassembly is a bifurcated graft.
 7. The repair graft assembly accordingto claim 3, wherein said proximal graft assembly comprises proximalattachment means for securing said proximal end of said graft to theproximal end of the vessel.
 8. The repair graft assembly according toclaim 7, wherein said proximal attachment means comprises a radiallyextending cuff.
 9. The repair graft assembly according to claim 8,wherein said proximal graft assembly is formed from a flexible material.10. The repair graft assembly according to claim 8, wherein saidproximal graft assembly is a bifurcated graft.
 11. The repair graftassembly according to claim 3, wherein said attachment means comprisesat least one graft attachment leg for receiving said distal end of saidproximal graft assembly.
 12. A repair graft assembly for repairing ananeurysm in a vessel having a vessel wall, wherein a fluid flows throughthe vessel, said repair graft assembly comprising:a graft assemblyincluding at least one tubular assembly, wherein said at least onetubular assembly is located within the vessel to isolate the aneurysmfrom the circulatory system such that the flow of fluid bypasses theaneurysm through said at least one tubular assembly; and at least onegraft attachment assembly for securing said graft assembly to the vesselwall, said at least one graft attachment assembly including a radiallyextending flexible attachment cuff, said flexible cuff includes an inneropen portion having an inner diameter and a free outer perimeter portionhaving an outer diameter, wherein said outer diameter is greater thansaid inner diameter, and at least one graft attachment tube extendingfrom said inner open portion of said flexible attachment cuff, whereinat least a portion of said at least one tubular assembly is receivedwithin said at least one graft attachment tube, wherein said flexibleattachment cuff accommodates expansion of the vessel without negativelyimpacting the connection between the vessel and said at least one graftattachment assembly.
 13. The repair graft assembly according to claim12, wherein said graft assembly includes a first end and a second end,wherein said at least one graft attachment assembly includes a pair ofgraft attachment assemblies, one of said pair of graft attachmentassemblies being secured to said first end and another of said pair ofgraft attachment assemblies being secured to said second end.
 14. Therepair graft assembly according to claim 12, wherein the vessel has afirst cross-sectional area, the aneurysm has a second cross-sectionalthat is greater than said first cross-sectional area, said at least onetubular assembly having a third cross-sectional area, wherein said thirdcross-sectional area is between said first cross-sectional area andsecond cross-sectional area.
 15. A repair system for repairing ananeurysm in a vessel having a vessel wall, wherein a fluid flows throughthe vessel, said repair system comprising:a repair graft assembly havinga graft assembly including at least one tubular assembly, wherein saidat least one tubular assembly is located within the vessel to isolatethe aneurysm such that the flow of fluid bypasses the aneurysm throughsaid at least one tubular assembly, said repair graft assembly furtherhaving at least one graft attachment assembly for securing said graftassembly to the vessel wall, said at least one graft attachment assemblyincluding a radially extending flexible attachment cuff, and at leastone graft attachment tube extending from said flexible attachment cuff,wherein at least a portion of said at least one tubular assembly isreceived within said at least one graft attachment tube; and at leastone fastener for securing said at least one graft attachment assembly tothe vessel wall, wherein said at least one fastener includes a firstportion located on one side of said flexible attachment cuff, a secondportion located on one side of the vessel wall, and an intermediateportion connecting to said first portion and said second portion, saidintermediate portion extending through the vessel wall and said flexibleattachment cuff, whereby said first portion, second portion and saidintermediate portion act to apply a compressive force to the flexibleattachment cuff and the vessel wall to secure said repair graft assemblyto the vessel.
 16. The repair system according to claim 15, wherein saidflexible attachment cuff accommodates expansion of the vessel withoutnegatively impacting the connection between the vessel and said at leastone graft attachment assembly.
 17. The repair system according to claim15, wherein said graft assembly includes a first end and a second end,wherein said at least one graft attachment assembly includes a pair ofgraft attachment assemblies, one of said pair of graft attachmentassemblies being secured to said first end and another of said pair ofgraft attachment assemblies being secured to said second end.
 18. Therepair system according to claim 15, wherein the vessel has a firstcross-sectional area, the aneurysm has a second cross-sectional that isgreater than said first cross-sectional area, said at least one tubularassembly having a third cross-sectional area, wherein said thirdcross-sectional area is between said first cross-sectional area andsecond cross-sectional area.
 19. The repair system according to claim15, wherein said at least one fastener includes a plurality offasteners, wherein each of said plurality of fasteners secures saidrepair graft assembly to the vessel wall under a compressive force.